Merck filed the supplemental biologics license application based on results from the phase II KEYNOTE-158 trial.
The FDA has granted a priority review to pembrolizumab (Keytruda) for the treatment of advanced cervical cancer with disease progression on or after chemotherapy.
The agency has set a PDUFA date of June 28, 2018. Merck, the developer of pembrolizumab, reported in a press release that this is the first time the FDA has given a priority review to an anti—PD-1 therapy in this disease.
“Advanced cervical cancer is an illness with a poor prognosis and a high unmet medical need. We look forward to working with the FDA on the review of this application to help bring Keytruda to previously-treated patients with advanced cervical cancer,” Roger Dansey, MD, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories, said in a statement.
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